Brief Title
HPV Genotyping by DR. HPV Genotyping in Vitro Diagnostic Device (IVD) Kit in Exfoliated Cells of the Uterine Cervix
Official Title
Human Papillomavirus Detection and Genotyping by DR. HPV Genotyping IVD Kit in Exfoliated Cells of the Uterine Cervix
Brief Summary
High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer.
HPV testing and risk stratification by genotyping has been recognized as an effective
cervical screening program. A chip for HPV DNA typing based on type-specific polymerase chain
reaction (PCR), DR. HPV Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common
HPV types including all high-risk types. We studied its agreement, sensitivity, and
specificity compared to DNA sequencing as the gold standard.
Detailed Description
High-risk type human papillomavirus (HPV) is the known etiological agent of cervical cancer.
HPV testing and risk stratification by genotyping has been recognized as an effective
cervical screening program. HPV detection is also applied for triage of atypical squamous
cells of undetermined significance and follow-up after treatment for cervical neoplasms. A
chip for HPV DNA typing based on type-specific polymerase chain reaction (PCR), DR. HPV
Genotyping IVD Kit (HPV-27) was developed for genotyping of 27 common HPV types including all
high-risk types. We studied its agreement, sensitivity, and specificity compared to DNA
sequencing as the gold standard.
One-thousand one-hundred and three (1103) subjects were enrolled between December 2012 and
December 2013 from Linkou Chang Gung Memorial Hospital, Mackay Memorial Hospital, Changhua
Christian Hospital, and Cathay General Hospital.
Study Type
Interventional
Primary Outcome
Agreement
Condition
Cervical Intraepithelial Neoplasia
Intervention
DR. Chip HPV genotyping IVD kit
Study Arms / Comparison Groups
study arm
Description: We projected a total of 1,100 study cases, which encompassed 100 cases of women with no intraepithelial lesion or malignancy (NILM) cytology, 300 cases of ASCUS, 300 cases of low grade squamous intraepithelial lesion (LSIL) and 400 cases high grade squamous intraepithelial lesion (HSIL) in cervical cytology.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
1103
Start Date
December 12, 2012
Completion Date
July 8, 2014
Primary Completion Date
December 30, 2013
Eligibility Criteria
Inclusion Criteria:
1. 21-65 y/o female with sexual exposure
2. Written informed consent
3. Either one of the following conditions:
3a. No previous history of abnormal cervical cytology or abnormal histology for women
enrolled in no intraepithelial lesion or malignancy (NILM) group 3b. Abnormal cervical
cytology other than atrophic change, reactive change or glandular cells favored of the
endometrial origin
Exclusion Criteria:
1. Current pregnancy
2. Previous total hysterectomy
3. Cervicovaginal infection required treatment
4. Received cervical ablative therapy within 1 year
Gender
Female
Ages
21 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT04333212
Organization ID
MA1103L9
Responsible Party
Principal Investigator
Study Sponsor
Chang Gung Memorial Hospital
Collaborators
Dr. Chip Biotechnology Incorporation
Study Sponsor
, ,
Verification Date
April 2020